Cleared Traditional

K040922 - VENTURE WIRE CONTROL CATHETER

K040922 is an FDA 510(k) clearance for VENTURE WIRE CONTROL CATHETER, manufactured by Velocimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K040922 · Velocimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
132d
Days
Class 2
Risk

K040922 is an FDA 510(k) clearance for the VENTURE WIRE CONTROL CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Velocimed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 18, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Velocimed, Inc. devices

FDA 510(k) Submission Details - K040922

510(k) Number K040922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date August 18, 2004
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 688
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K040922.
6F Z4 GUIDE CATHETER
K042489 · Medtronic Vascular · Dec 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp · Oct 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · Medtronic Vascular · Sep 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · Concentric Medical, Inc. · Aug 2004
CONCENTRIC RETRIEVER X5, MODEL 90035
K040700 · Concentric Medical, Inc. · Jun 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · Medtronic Vascular · May 2004